The Recall Desk
HighFDA (Devices)·Z-2116-2025·Announced 2025-07-23

SwabCap Disinfecting Cap Needlefree Connector Seal Defect Recall

ICU Medical is recalling SwabCap Disinfecting Caps due to a manufacturing defect that may prevent proper disinfection of needlefree connectors. The incomplete seal may cause isopropyl alcohol to evaporate, reducing effectiveness.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II medical device where manufacturing defects may result in inadequate disinfection capability. The hazard is theoretical with no reported injuries or illnesses, meeting the High severity threshold for risk-of-harm products without reported harm.

Plain-English summary

ICU Medical, Inc. is recalling SwabCap Disinfecting Caps for Needlefree Connectors (SwabSleeve and 200-count Box variants). The recall affects 1,445,600 units distributed nationwide and worldwide.

The affected products may have an incomplete seal between the foil lid and plastic container. This manufacturing issue may allow isopropyl alcohol to evaporate from the sponge inside the cap. When alcohol evaporates, the disinfecting effectiveness of the product is reduced, which may result in inadequate disinfection of the needlefree connector.

Healthcare facilities and providers using these products are potentially affected. The recalled products are identified by specific reference numbers (SCXT3-5-2000 and SCXT3-2000) and specific lot codes provided by the manufacturer.

Consumers and healthcare facilities should stop using the affected product immediately and contact ICU Medical or their healthcare supplier for instructions on return or replacement.

The recalled product

Product
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infection Prevention
Hazard
  • inadequate-disinfection
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF/UDI-DI/Lot(Expiration): SCXT3-5-2000/10887709097107/14258739(1-Dec-26)
  • 14258743(1-Feb-26)
  • 14258744(1-Dec-26)
  • 14264200(1-Dec-26)
  • 14272241(1-Dec-26)
  • 14272248(1-Dec-26)
  • 14287456(1-Dec-26)
  • 14287459(1-Dec-26)
  • 14287480(1-Dec-26)
  • 14287482(1-Dec-26)
  • 14287485(1-Dec-26)
  • 14294832(1-Dec-26)
  • 14272254(1-Dec-26)
  • 14310313(1-Dec-26)
  • 14310425(1-Dec-26)
  • 14323354(1-Dec-26)
  • 14287475(1-Dec-26)
  • 14294840(1-Dec-26)
  • 14321645(1-Jan-27)
  • 14321652(1-Jan-27)

Distribution

Distributed nationwide across the United States.

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